U.S. patent application number 17/418618 was filed with the patent office on 2022-03-17 for intervention guidance device.
This patent application is currently assigned to Lifetech Scientific (Shenzhen) Co., Ltd.. The applicant listed for this patent is Lifetech Scientific (Shenzhen) Co., Ltd.. Invention is credited to Wei Jiang, Xiangdong Liu, Huixiong Xie, Bin Yao.
Application Number | 20220079751 17/418618 |
Document ID | / |
Family ID | 1000006047091 |
Filed Date | 2022-03-17 |
United States Patent
Application |
20220079751 |
Kind Code |
A1 |
Yao; Bin ; et al. |
March 17, 2022 |
Intervention Guidance Device
Abstract
An intervention guidance device (10) includes a main body
portion (100) and a guidance portion (200). The guidance portion
(200) has a contracted configuration and an expanded configuration.
In the expanded configuration, the guidance portion (200) has a
central area (201) and a closed outer edge (202). In the contracted
configuration, the outer edge (202) is farther away from the main
body portion (100) than the central area (201), and the guidance
portion (200) is restorable from the contracted configuration to
the expanded configuration. In the intervention guidance device
(10), the radial dimension of the guidance portion (200) is larger
than the distance between the chordae tendineae, so that an
effective access path that does not cross the chordae tendineae can
be established, the subsequent implantation of a heart valve
prosthesis does not pass through the chordae tendineae, and the
success rate of a heart valve prosthesis implantation surgery can
be improved.
Inventors: |
Yao; Bin; (Shenzhen, CN)
; Liu; Xiangdong; (Shenzhen, CN) ; Jiang; Wei;
(Shenzhen, CN) ; Xie; Huixiong; (Shenzhen,
CN) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Lifetech Scientific (Shenzhen) Co., Ltd. |
Shenzhen |
|
CN |
|
|
Assignee: |
Lifetech Scientific (Shenzhen) Co.,
Ltd.
Shenzhen
CN
|
Family ID: |
1000006047091 |
Appl. No.: |
17/418618 |
Filed: |
July 10, 2019 |
PCT Filed: |
July 10, 2019 |
PCT NO: |
PCT/CN2019/095419 |
371 Date: |
June 25, 2021 |
Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 2017/00743
20130101; A61F 2/2436 20130101; A61F 2/2418 20130101; A61F 2/2457
20130101; A61B 17/02 20130101; A61F 2/2466 20130101; A61M 25/09
20130101 |
International
Class: |
A61F 2/24 20060101
A61F002/24; A61B 17/02 20060101 A61B017/02; A61M 25/09 20060101
A61M025/09 |
Foreign Application Data
Date |
Code |
Application Number |
Dec 27, 2018 |
CN |
201811615406.5 |
Claims
1. An intervention guidance device, comprising: a main body
portion; and a guidance portion having a contracted configuration
used for delivery and a predetermined expanded configuration, in
the expanded configuration, the guidance portion has a central area
and a closed outer edge formed by the outward expansion of the
central area, and a distal end of the main body portion is
connected to the central area; and in the contracted configuration,
the outer edge is farther away from the main body portion than the
central area, and when the outer edge of the guidance portion
extends beyond a plane of a distal end of a delivery tube, the
guidance portion is restorable from the contracted configuration to
the expanded configuration.
2. The intervention guidance device according to claim 1, wherein
the guidance portion is a planar body.
3. The intervention guidance device according to claim 1, wherein
the guidance portion comprises a woven mesh woven by a plurality of
mesh wires and a plug used for gathering and fixing the mesh wires
at a closed end of the woven mesh, the plug is located in the
central area, and the mesh wires at the closed end of the woven
mesh located at a distal end of the woven mesh are fixed to the
plug after being bent from the distal end to a proximal end.
4. The intervention guidance device according to claim 3, wherein
the woven mesh comprises a distal-end mesh surface and a
proximal-end mesh surface which are integrally connected, the
proximal-end mesh surface is closer to the main body portion than
the distal-end mesh surface, the mesh wires at the closed end of
the distal-end mesh surface pass through the proximal-end mesh
surface and then are converged together with the mesh wires at the
closed end of the proximal-end mesh surface, and the converged mesh
wires are gathered and fixed by the plug.
5. The intervention guidance device according to claim 3, wherein
the woven mesh is woven from not less than 16 mesh wires, and a
wire diameter of each mesh wire is in a range from 0.0028 inch to
0.0060 inch.
6. The intervention guidance device according to claim 3, wherein
the plug is provided with threads for rotational connection with
the main body portion.
7. An intervention guidance device, comprising: a main body
portion; and a guidance portion having a contracted configuration
used for delivery and a predetermined expanded configuration, and
the guidance portion comprises a woven mesh woven from a plurality
of mesh wires and a plug used for gathering and fixing the mesh
wires at the closing position of the woven mesh, the mesh wires at
a closed end of the woven mesh located at a distal end of the woven
mesh are fixed to the plug after being bent from the distal end to
a proximal end, and the guidance portion is fixedly connected to a
distal end of the main body portion through the plug.
8. The intervention guidance device according to claim 7, wherein
the woven mesh comprises a distal-end mesh surface and a
proximal-end mesh surface which are integrally connected, the
proximal-end mesh surface is closer to the main body portion than
the distal-end mesh surface, the mesh wires at the closed end of
the distal-end mesh surface pass through the proximal-end mesh
surface and then are converged together with the mesh wires at the
closed end of the proximal-end mesh surface, and the converged mesh
wires are gathered and fixed by the plug.
9. The intervention guidance device according to claim 7, wherein
the woven mesh is woven from not less than 16 mesh wires, and each
mesh wire has a wire diameter of 0.0028 inch to 0.0060 inch.
10. The intervention guidance device according to claim 7, wherein
the plug is provided with threads for rotational connection with
the main body portion.
Description
FIELD
[0001] The present disclosure relates to the field of medical
devices and in particular to an intervention guidance device.
BACKGROUND
[0002] This section provides only background information related to
the disclosure, which is not necessarily the prior art.
[0003] As shown in FIG. 1, a human heart is divided into a left
heart system and a right heart system. The left heart system
includes a left atrium LA and a left ventricle LV. The right heart
system includes a right atrium RA and a right ventricle RV. The
left atrium LA, the left ventricle LV, the right atrium RA, and the
right ventricle RV divide the heart into four chambers. Each
chamber has a respective "outlet" at which a mitral valve MV, an
aortic valve, a tricuspid valve WV, and a pulmonary valve are
arranged respectively. The four valves allow the blood pumped by
the heart to circulate in the cardiovascular system in the
specified direction. The mitral valve MV is located between the
left atrium LA and the left ventricle LV and is connected to the
papillary muscles in the left ventricle LV by the chordae
tendineae. The normal mitral valve MV is able to circulate a
certain amount of blood from the left atrium LA to the left
ventricle LV during blood circulation, and when the left ventricle
LV contracts, two flexible leaflets of the mitral valve MV are
closed, thereby preventing blood from flowing back from the left
ventricle LV to the left atrium LA. However, various heart diseases
and degenerative diseases can lead to dysfunction of the mitral
valve MV, causing the mitral valve MV to become abnormally
constricted or dilated, resulting in the backflow of blood from the
left ventricle LV into the left atrium LA. Therefore, the loss of
function and damage of the mitral valve MV can affect the normal
operation of the heart, resulting in the gradual weakening of the
heart function and even life-threatening.
[0004] For the loss of function and damage of the mitral valve MV,
there are currently a number of treatment methods and devices for
treating mitral valve dysfunction, such as a conventional valve
replacement surgery, which is known as an "open heart" surgery. In
short, the valve replacement surgery requires opening the chest,
using a ventilator, initiating extracorporeal circulation, stopping
and opening the heart, and then removing and replacing the
patient's mitral valve MV. The valve replacement surgery has a high
medical risk due to the complexity of extracorporeal circulation
and poor tolerability of elderly patients. Therefore, there is a
growing interest in the treatment of the mitral valve MV by
interventional means, such as less heart-invasive transcatheter
technologies developed for the delivery of replacement mitral valve
components, in which a self-expanding prosthetic valve is typically
mounted in a compressed state at the end of a flexible catheter and
advanced through the patient's blood vessel or body until the
prosthetic valve reaches an implantation position, and then the
prosthetic valve dilates to the functional size and state thereof
at a position of a defective native mitral valve.
[0005] As shown in FIG. 2, a mitral valve prosthesis 1 includes a
valve skirt 11, a valve stent body 12, leaflets (not shown in
figure), and a tether 13. The valve skirt 11 has an outer diameter
larger than an opening of a mitral valve MV. The valve skirt 11 is
located on the side of a left atrium LA after implantation of the
mitral valve prosthesis 1 into the heart. Therefore, the mitral
valve prosthesis 1 is "located" on tissue at a mitral valve opening
as a whole, and does not fall off from one side of the left atrium
LA to the left ventricle LV. The valve stent body 12 is located at
a native mitral valve position. The tether 13 is attached to a
distal end of the valve stent body 12 and fixed to the position of
an apex of the heart. The mitral valve prosthesis 1 may be stably
arranged on the tissue at the mitral valve opening, is not easily
dislodged from a native mitral valve leaflet, and does little
damage to the native mitral valve leaflet. The service life of the
mitral valve prosthesis 1 can be prolonged, and the risks of a
secondary replacement valve surgery for a patient can be
reduced.
[0006] As shown in FIG. 3, both ends of chordae tendineae 21 in a
left ventricle LV are connected to a papillary muscle 22 and a
mitral valve leaflet 23 respectively, and the chordae tendineae 21
and the papillary muscle 22 pull the mitral valve leaflet 23 so
that it does not flip toward the left atrium LA, thereby preventing
blood in the left ventricle LV from flowing back to the left atrium
LA. Since the tether 13 is connected to a tail end of the mitral
valve prosthesis 1 in FIG. 2 and a plurality of chordae tendineae
21 are separated from one same papillary muscle 22, a large gap 24
exists between the chordae tendineae 21, so that related devices
can easily pass through the gap 24 between the chordae tendineae 21
during the process of establishing an implantation path of the
mitral valve prosthesis 1. Since the tether 13 also passes through
the gap 24 between the chordae tendineae 21 after the mitral valve
prosthesis 1 is implanted at an opening of a mitral valve MV, and
the mitral valve prosthesis 1 cannot be placed coaxially at the
opening of the mitral valve MV, perivalvular leakage of the mitral
valve prosthesis 1 can occur. In addition, in recent years,
scholars consider that the chordae tendineae 21 are related to
heart murmur, arrhythmia, chest pain, chest tightness, and
palpitation. Therefore, it is particularly important to establish a
proper implantation path of an artificial heart valve 1 so that an
implantation track of the artificial heart valve does not cross the
gap 24 between the chordae tendineae 21. Moreover, the proper
implantation path of the artificial heart valve can reduce damage
to the chordae tendineae 21 caused by the surgery, and the
artificial heart valve can be coaxially released at the opening of
the mitral valve MV, so that the probability of perivalvular
leakage of the artificial heart valve can be reduced.
SUMMARY
[0007] An object of the disclosure is to provide an intervention
guidance device which can contribute to the establishment of an
effective path, and the object of the disclosure is mainly achieved
by the following technical solution.
[0008] An intervention guidance device includes:
[0009] a main body portion; and
[0010] a guidance portion having a contracted configuration used
for delivery and a predetermined expanded configuration, in the
expanded configuration, the guidance portion has a central area and
a closed outer edge formed by the outward expansion of the central
area, and a distal end of the main body portion is connected to the
central area; and in the contracted configuration, the outer edge
is farther away from the main body portion than the central area,
and when the outer edge of the guidance portion extends beyond the
plane of a distal end of a delivery tube, the guidance portion is
restorable from the contracted configuration to the expanded
configuration.
[0011] An intervention guidance device includes:
[0012] a main body portion; and
[0013] a guidance portion having a contracted configuration used
for delivery and a predetermined expanded configuration, and the
guidance portion includes a woven mesh woven by a plurality of mesh
wires and a plug used for gathering and fixing the mesh wires at a
closed end of the woven mesh, the mesh wires at the closed end of
the woven mesh located at a distal end of the woven mesh are fixed
to the plug after being bent from the distal end to a proximal end,
and the guidance portion is fixedly connected to a distal end of
the main body portion through the plug.
[0014] The above intervention guidance devices, by providing the
guidance portion with the radial dimension larger than the distance
between the chordae tendineae, can establish an effective access
path that does not cross the chordae tendineae, where the
subsequent implantation of a heart valve prosthesis does not pass
through the chordae tendineae, and the success rate of a heart
valve prosthesis implantation surgery can be improved.
BRIEF DESCRIPTION OF THE DRAWINGS
[0015] Various other advantages and benefits will become apparent
to those of ordinary skill in the art upon reading the following
detailed description of the preferred implementations. The drawings
are only for purposes of illustrating the preferred implementations
and are not to be construed as limiting the disclosure. In
addition, throughout the drawings, the same reference numerals
represent the same components. In the drawings:
[0016] FIG. 1 is a schematic diagram of the structure of various
chambers and mitral valves in a heart system;
[0017] FIG. 2 is a schematic diagram of the structure of a
conventional mitral valve prosthesis;
[0018] FIG. 3 is a schematic diagram of internal structure of a
left atrium and a left ventricle;
[0019] FIG. 4 is a schematic diagram of structure of an
intervention guidance device according to an embodiment of the
disclosure;
[0020] FIG. 5 is a schematic diagram of the structure of the
intervention guidance device shown in FIG. 4 from another
perspective;
[0021] FIG. 6 is an exploded view of the intervention guidance
device shown in FIG. 4;
[0022] FIG. 7 is a schematic diagram of the structure of the
intervention guidance device shown in FIG. 4 loaded into a delivery
tube;
[0023] FIG. 8 is a schematic diagram of the structure of the
intervention guidance device shown in FIG. 4 being released from
the delivery tube;
[0024] FIG. 9 is a schematic diagram of the structure of the
intervention guidance device shown in FIG. 4 loaded into a delivery
tube and placed into a ventricle;
[0025] FIG. 10 is a schematic diagram of the structure of the
intervention guidance device shown in FIG. 4 after a guidance
portion is pushed out of the delivery tube;
[0026] FIG. 11 is a schematic diagram of the structure of the
intervention guidance device shown in FIG. 4 being pushed in a left
ventricle;
[0027] FIG. 12 is a schematic diagram of the structure of the
intervention guidance device shown in FIG. 4 after being pushed
into a left atrium;
[0028] FIG. 13 is a schematic diagram of the structure of the
intervention guidance device shown in FIG. 4 being pushed in a
blood vessel;
[0029] FIG. 14 is a schematic diagram of the structure of the
intervention guidance device shown in FIG. 4 at a branch blood
vessel;
[0030] FIG. 15 is a schematic diagram of the structure of an
intervention guidance device loaded into a delivery tube in the
prior art;
[0031] FIG. 16 is a schematic diagram of the structure of the
intervention guidance device shown in FIG. 15 released from the
delivery tube;
[0032] FIG. 17 is a schematic diagram of the structure of the
intervention guidance device shown in FIG. 15 after being released
from the delivery tube;
[0033] FIG. 18 is a schematic diagram of the structure of forming
an apical pericardium on a heart;
[0034] FIG. 19 is a schematic diagram of the structure of an apical
puncture needle extending into the left ventricle;
[0035] FIG. 20 is a schematic diagram of the structure of the
delivery tube extending into the left ventricle;
[0036] FIG. 21 is a schematic diagram of the structure of the
intervention guidance device placed into the delivery tube;
[0037] FIG. 22 is a schematic diagram of the structure of the
intervention guidance device being pushed into the left
ventricle;
[0038] FIG. 23 is a schematic diagram of the structure of the
intervention guidance device after being pushed into the left
atrium;
[0039] FIG. 24 is a schematic diagram of the structure of an
vitro-left ventricle-left atrium track established by the
intervention guidance device;
[0040] FIG. 25 is a schematic diagram of the structure of an apical
dilated sheath and a sheath core extending into the left
atrium;
[0041] FIG. 26 is a schematic diagram of the structure of a valve
delivery device inserted into the left atrium;
[0042] FIG. 27 is a schematic diagram of the structure of a valve
prosthesis partially released in the valve delivery device;
[0043] FIG. 28 is a schematic structure view of a valve body of the
valve prosthesis after being released from the valve delivery
device; and
[0044] FIG. 29 is a schematic diagram of the structure of the valve
prosthesis after implantation.
DETAILED DESCRIPTION OF THE DISCLOSURE
[0045] In order that the above objects, features, and advantages of
the disclosure can be more readily understood, specific
implementations of the disclosure will be described below in detail
with reference to the accompanying drawings. In the following
description, numerous specific details are set forth in order to
provide a thorough understanding of the disclosure. The disclosure
may, however, be embodied in many different forms than those herein
set forth, and such modifications as would occur to those skilled
in the art may be made without departing from the spirit and scope
of the disclosure.
[0046] It will be understood that when an element is referred to as
being "fixed" or "arranged" to another element, it may be directly
on another element or an intermediate element may also be present.
When an element is referred to as being "connected" to another
element, it may be directly connected to another element or an
intermediate element may be present at the same time. The terms
"vertical", "horizontal", "left", "right" and the like as used
herein are for illustrative purposes only and are not meant to be
the only implementations.
[0047] Unless defined otherwise, all technical and scientific terms
used herein have the same meaning as commonly understood by those
skilled in the art to which the disclosure belongs. The terms used
in the description of the disclosure herein are for the purpose of
describing specific implementations only and are not intended to be
limiting of the disclosure. The term "and/or" as used herein
includes any and all combinations of one or more of the associated
listed items.
[0048] It should be noted that in the field of intervention medical
instruments, an end of a medical instrument implanted in a human or
animal body that is closer to an operator is generally referred to
as a "proximal end", an end that is further away from the operator
is referred to as a "distal end", and the "proximal end" and
"distal end" of any component of the medical instrument are defined
in accordance with this principle. An "axial direction" generally
refers to a longitudinal direction of the medical instrument when
being delivered, and a "radial direction" generally refers to a
direction of the medical instrument perpendicular to the "axial
direction" thereof, and the "axial direction" and "radial
direction" of any component of the medical instrument are defined
in accordance with this principle.
[0049] Referring to FIG. 4, an intervention guidance device 10
provided in the disclosure includes a main body portion 100 and a
guidance portion 200. The guidance device 200 is connected to a
distal end of the main body portion 100.
[0050] The guidance portion 200 has a contracted configuration used
for delivery and a predetermined expanded configuration. Referring
to FIG. 4, in the expanded configuration, the guidance portion 200
has a central area 201 and a closed outer edge 202 formed by the
outward expansion of the central area 201, and the distal end of
the main body portion 100 is connected to the central area 201.
Referring to FIGS. 7 and 8 together, in the contracted
configuration, for example in a delivery tube 20, the outer edge
202 is farther away from the main body portion 100 than the central
area 201, that is, a maximum radial dimension position in the
expanded configuration is in the delivery tube 20 furthest from the
main body portion 100. When the main body portion 100 is pushed to
cause the guidance portion 200 to move out of the delivery tube 20,
and when the outer edge 202 of the guidance portion 200 extends
beyond the plane of a distal end of the delivery tube 20, the
guidance portion 200 is restorable from the contracted
configuration to the expanded configuration. In the present
embodiment, the guidance portion 200 is a planar body. Of course,
in other embodiments, the guidance portion 200 is not necessarily
limited to the planar body, and the guidance portion 200 may be in
other configurations. As long as the outer edge 202 of the guidance
portion 200 extends beyond the plane of the distal end of the
delivery device 20, the guidance portion 200 can be quickly
restored from the contracted configuration to the expanded
configuration.
[0051] It should be noted that when a distance by which the outer
edge 202 of the guidance portion 200 may extend beyond the plane of
the distal end of the delivery tube 20 is much less than a maximum
radial dimension of the outer edge 202 of the guidance portion 200,
for example, when the distance by which the outer edge 202 of the
guidance portion 200 may extend beyond the plane of the distal end
of the delivery tube 20 is less than 1/2, 1/3, 1/4, 1/5, 1/6 or
less of the maximum radial dimension of the outer edge 202 of the
guidance portion 200, the guidance portion 200 can spring out of
the delivery tube 20 and can be restored from the contracted
configuration to the expanded configuration. The radial dimension
in the disclosure refers to the length of a connecting line of the
outer edge 202 across a center point of the central area 201. For
example, when the guidance portion 200 is disc-shaped, the radial
dimension is a diameter.
[0052] In the illustrated embodiments, the outer edge 202 of the
guidance portion 200 is also further from the main body portion
than the central area 201 in the expanded configuration. More
specifically, the plane in which the outer edge 202 of the guidance
portion 200 is located is a furthest end surface of the
intervention guidance device 10. It will be appreciated that in
other embodiments, the outer edge 202 of the guidance portion 200
may also be bent to a proximal end in the expanded configuration,
that is, the plane in which the end of the outer edge 202 of the
guidance portion 200 is located is not necessarily located in the
furthest end surface of the intervention guidance device 10.
[0053] In the illustrated embodiments, the central area 201 is
recessed from the distal end to the proximal end so as to
facilitate rapid restoration of the guidance portion 200 from the
contracted configuration to the expanded configuration. In one
embodiment, the recess extends to a position connected to the main
body portion 100.
[0054] In one embodiment, referring to FIG. 5 together, the
guidance portion 200 includes a woven mesh 210 woven by a plurality
of mesh wires and a plug 220 used for gathering and fixing the mesh
wires at the closed end of the woven mesh 210, the mesh wires at
the closed end located at a distal end of the woven mesh 210 are
fixed to the plug 220 after being bent from the distal end to a
proximal end, and the guidance portion 200 is fixedly connected to
the distal end of the main body portion 100 through the plug 220.
The mesh wires may be superelastic metal or shape memory metal,
such as nitinol.
[0055] It will be appreciated that in other embodiments, the plug
220 may be omitted. For example, the mesh wires at the closed end
may be gathered and fixed by welding or the like.
[0056] In the illustrated embodiments, the woven mesh 210 includes
a distal-end mesh surface 211 and a proximal-end mesh surface 213
which are integrally connected. The proximal-end mesh surface 213
is closer to the main body portion 100 than the distal-end mesh
surface 211. The mesh wires at the closed end of the distal-end
mesh surface 211 pass through the proximal-end mesh surface 213 and
then are converged together with mesh wires at the closed end of
the proximal-end mesh surface 213, and the converged mesh wires are
gathered and fixed by the plug 220. Specifically, the woven mesh
210 may be woven into a cylindrical tubular body by mesh wires. The
mesh wires at the closed end of a distal end of the tubular body
are reversed to be converged with the mesh wires at the closed end
of a proximal end and are closed and fixed by the plug 220 to form
a planar body in which the distal-end mesh surface 211 and the
proximal-end mesh surface 213 are attached to each other by
heat-setting. In one embodiment, the woven mesh 210 is woven from
not less than 16 mesh wires, and each mesh wire has a wire diameter
of 0.0028 inch to 0.0060 inch. In one embodiment, the woven mesh
210 is woven from 36 to 72 mesh wires to maintain the radial
deformability of the woven mesh 210 and to increase an average mesh
area of the woven mesh 210. In the illustrated embodiments, the
woven mesh 210 is shaped into a planar disc-shaped structure having
a diameter of 10 mm to 25 mm. Of course, in other embodiments, the
woven mesh 210 can also be shaped into other structures, such as a
bowl-shaped structure recessed from the distal end to the proximal
end. When the cross section of the woven mesh 210 is not circular,
the woven mesh 210 has a radial dimension of 10 mm and 25 mm, that
is, a straight line across the central area has a length of 10 mm
and 25 mm.
[0057] Referring to FIG. 6, the plug 220 is provided with a
threaded hole 221 for rotational connection with the main body
portion 100. In the illustrated embodiments, the plug 220 is
provided with internal threads, and the main body portion 100 is
provided with external threads. In other embodiments, the plug 220
may also be provided with external threads, and the main body
portion 100 is provided with internal threads. Of course, the main
body portion 100 may also be fixedly connected to the plug 220 in
other ways, such as welding.
[0058] The plug 220 may be made of stainless steel or nitinol. The
main body portion 100 may be of a metallic or non-metallic
structure. In one embodiment, the main body portion 100 is made of
stainless steel or nitinol. The main body portion 100 may have a
solid structure. For example, the main body portion 100 may have a
rod-like structure formed by a single wire or a cable structure
formed by winding a plurality of wires. The main body portion 100
may have a hollow structure. The main body portion 100 may have an
outer diameter between 1 mm and 3 mm.
[0059] Referring together to FIGS. 7 and 8, when the main body
portion 100 passes through the delivery tube 20 and is pulled from
the proximal end, the guidance portion 200 may be deformed into the
delivery tube 20. At this moment, the outer edge 202 of the
guidance portion 200 is located at the furthermost end, and the
central area 201 is pulled to the proximal end. When the main body
portion 100 is pushed distally, the guidance portion 200 may be
quickly restored to the expanded configuration as the outer edge of
the guidance portion 200 is pushed out of the delivery tube 20.
[0060] It will be appreciated that the guidance portion 200 is not
necessarily limited to a woven mesh structure. For example, the
guidance portion 200 may also be a body planar structure formed by
cutting. As long as the guidance portion 200 just extends out of
the delivery tube, the guidance portion 200 may be instantly
restored from the contracted configuration to the expanded
configuration.
[0061] The intervention guidance device 10 may be used as a guide
wire for establishing an access track for a mitral valve
prosthesis. Referring together to FIGS. 9 and 12, the intervention
guidance device 10 is loaded into the delivery tube 20, and the
delivery tube 20 enters a left ventricle from an apical position,
with the distal end of the delivery tube 20 being at the bottom of
the left ventricle. The main body portion 100 is slowly pushed
distally, and when the distal end of the guidance portion 200 is
pushed out of the delivery tube 20, the guidance portion 200 is
quickly restored from the contracted configuration to the expanded
configuration, and may adapt to the bottom of papillary muscles and
conform to the shape of an inner wall of the heart. In the left
ventricle, when the main body portion 100 is pushed distally, the
guidance portion 200 may be attached to surrounding tissues and
chordae tendineae 21. Since the radial dimension of the guidance
portion 200 is larger than a gap 24 between the chordae tendineae
21, the guidance portion 200 does not enter the area between the
chordae tendineae 21, and the chordae tendineae 21 pulled by the
papillary muscles 22 in the ventricle may be radially pushed away
by the guidance portion 200. The main body portion 100 is
continuously pushed distally to a mitral valve leaflet 23, and when
the left ventricle relaxes, the mitral valve leaflet 23 is in an
opened state. Then the main body portion 100 is pushed, and the
guidance portion 200 can enter a left atrium through the mitral
valve leaflet 23 to establish a vitro-left ventricle-left atrium
access path.
[0062] In the above intervention guidance device 10, by providing
the guidance portion 200 with a radial dimension larger than the
distance between the chordae tendineae, an effective access path
can be established that does not cross the chordae tendineae, where
the subsequent implantation of a heart valve prosthesis does not
pass through the chordae tendineae. Therefore, the success rate of
a heart valve prosthesis implantation surgery can be improved.
[0063] The intervention guidance device 10 may also be used in a
peripheral vascular surgery. In an aortic valve replacement
surgery, the intervention guidance device 10 may be used as a guide
wire to establish an access path for an aortic valve prosthesis. A
general guide wire is often impacted by blood in the process of
establishing an access, and a distal end of the guide wire is
easily influenced by blood flow to enter a branch blood vessel of
an aortic arch part, so that many problems are introduced to the
surgery. However, the intervention guidance device 10 of the
present disclosure can effectively avoid these problems. Referring
to FIGS. 13 to 14, the intervention guidance device 10 enters a
descending aorta 30 through an arterial vessel of a lower limb.
When the guidance portion 200 encounters a branch blood vessel 31,
because the radial dimension of the guidance portion 200 is larger
than an opening of the branch blood vessel 31, the guidance portion
200 can avoid the branch blood vessel 31 instead of entering the
branch blood vessel 31, thereby smoothly establishing an access
path of an aortic valve prosthesis. In addition, the guidance
portion 200 can also adapt to the shape of the inner wall of the
blood vessel. The image can clearly show the shape of the blood
vessel during the access process.
[0064] It should be noted that some guidance devices for ultrasound
intervention are known in the prior art. Referring to FIGS. 15 to
17, an end of an intervention guidance device 40 is generally
provided with a mesh-like three-dimensional structure 41 such as a
sphere and an ellipsoid in order to be better shown under an
ultrasound medium. After the intervention guidance device 40 is
loaded into a delivery tube 20, a central area of the
three-dimensional structure 41 may be located at two ends, and an
outer edge may be located between the two ends. For example, the
three-dimensional structure 41 will be contracted to a linear
structure. When being pushed distally, the three-dimensional
structure 41 needs to be pushed out for a certain distance, so that
the distance of the three-dimensional structure 41 extending out of
the delivery tube 20 is not less than a distance of a maximum
radial dimension of the three-dimensional structure 41. Therefore,
the three-dimensional structure 41 can be restored from a
contracted state to an expanded state. When the intervention
guidance device 40 is applied to an implantation surgery of a valve
prosthesis, since the three-dimensional structure 41 needs to be
pushed out of the delivery tube 41 for a long distance when the
three-dimensional structure 41 is restored from the contracted
state to the expanded state, the three-dimensional structure 41 may
pass through some chordae tendineae at the bottom of a ventricle
before the three-dimensional structure 41 is restored to the
expanded state. Therefore, the established access path cannot be
prevented from completely avoiding the chordae tendineae. In the
intervention guidance device 10 of the disclosure, since a distance
of the guidance portion 200 extending out of the delivery tube 20
may be much less than the maximum radial dimension of the outer
edge (the extending distance is less than 1/2 of the maximum radial
dimension of the outer edge, or the extending distance may be
ignored with respect to the maximum radial dimension of the outer
edge), the guidance portion 200 can be instantly restored from the
contracted configuration to the expanded configuration. Therefore,
the guidance portion 200 can be completely prevented from extending
into a gap of the chordae tendineae, thereby improving the success
rate of a valve prosthesis implantation surgery.
[0065] In addition, because the expanded state of the guidance
portion 200 has a large area, the guidance portion 20 may be
detected by ultrasound and digital subtraction angiography (DSA)
and has wide adaptability. Moreover, the position and shape of
tissues are clearly determined by the shape of the guidance portion
200.
[0066] Referring to FIGS. 18 to 29, the disclosure also provides a
method for implanting a valve prosthesis. The method includes the
following steps: S11: an incision is formed in a left chest to
expose a ventricle; S12: an access path is established from the
ventricle to an atrium using an intervention guidance device 10 and
which avoids chordae tendineae; S13: a valve prosthesis 1 is placed
along the intervention guidance device 10 at a native valve between
the ventricle and the atrium through a valve delivery device 2. The
method for implanting a valve prosthesis provided by the disclosure
may effectively avoid the gap 24 between the chordae tendineae 21
during the process of establishing an access path of the valve
prosthesis 1, so that the phenomenon that a tether 13 on the valve
prosthesis 2 passes through the gap 24 between the chordae
tendineae 21 can be reduced during the implantation process of the
valve prosthesis 2. Therefore, the phenomenon that the valve
prosthesis 2 cannot be coaxially placed with the native valve
because the tether 13 passes through the gap 24 between the chordae
tendineae 21 during the implantation process of the valve
prosthesis 2 is reduced, and the phenomenon of perivalvular leakage
after the implantation of the valve prosthesis 2 is reduced.
Meanwhile, the access path of the disclosure can effectively reduce
damage to the chordae tendineae 21 when the tether 13 of the valve
prosthesis 2 is hung on the chordae tendineae 21 during the
implantation process.
[0067] For the convenience of describing the method for implanting
an artificial heart valve of the disclosure, the disclosure is
described by applying the method for implanting an artificial heart
valve to an implantation surgery of the mitral valve prosthesis 1.
Referring to FIG. 18, step S11 includes the following steps:
[0068] S111, an incision is made in an interval between the fifth
and sixth ribs of the left chest, and an apex of a left ventricle
LV is exposed after opening a pericardium longitudinally through
the incision;
[0069] S112, an apical pericardium 301 is sutured at the apex of
the left ventricle LV;
[0070] When the surgery of the valve prosthesis 2 is completed,
tissues at an apical puncture may be pressed together by tightening
the apical pericardium 301, which helps to improve the healing
effect and the healing speed of the tissues at the apical
puncture.
[0071] Referring to FIGS. 19 to 24, step S12 includes the following
steps:
[0072] S121: an apical puncture needle 310 is used to puncture the
apex of the left ventricle LV at the position of the apical purse
301 to form a puncture hole;
[0073] S122, a delivery tube 20 extends into the left ventricle LV
through the puncture of the apical pericardium 301, and a
positional relationship between the delivery tube 20 and a
ventricular wall is adjusted according to imaging (for example, DSA
image) such that a distal end of the delivery tube 20 just enters
the left ventricle LV or is exposed within 10 mm;
[0074] S123, the intervention guidance device 10 is placed into a
tube cavity of the delivery tube 20, and with the aid of imaging
(for example, DSA image or ultrasound image), the intervention
guidance device 10 is slowly pushed distally into the left
ventricle LV so that an outer edge of a guidance portion 200 is
just pushed out of the distal end of the delivery tube 20 and is
restored to an expanded configuration within the left ventricle
LV.
[0075] S124, the intervention guidance device 10 continues to be
pushed until the guidance portion 200 is pushed into the left
atrium LA. Specifically, the morphologic change of the guide
portion 200 is observed with the aid of imaging to see if the
distal end of the guidance portion 200 is bent to the proximal end;
for example, as shown in FIG. 22, the distal end of the guidance
portion 200 is bent to the proximal end by the chordae tendineae
21. After that, the intervention guidance device 10 is withdrawn to
the apex. The angle of the delivery tube 20 and a ventricular wall
is adjusted, and the intervention guidance device 10 is slowly
pushed toward the left atrium LA again. The guidance portion 200
cannot be bent in the pushing process. If it is bent, the
intervention guidance device 10 should be withdrawn. The step is
repeated until the guidance portion 200 is pushed into the left
atrium LA.
[0076] S125, the delivery tube 20 is withdrawn, and the
intervention guidance device 10 is retained in the heart to obtain
a vitro-left ventricle-left atrium track.
[0077] Referring to FIGS. 25 to 29, step S13 includes the following
steps:
[0078] S131, an apical dilated sheath 341 and a sheath core 342
extend along the main body portion 100 into the left ventricle LV,
and reach the left atrium LA across the mitral valve MV. The
structure of the apical dilated sheath 341 and the sheath core 342
is known in the prior art and will not be described in detail
herein.
[0079] S132, the apical dilated sheath 341 is fixed, the sheath
core 342 and the intervention guidance device 10 are withdrawn from
the heart, and the valve delivery device 2 delivers the valve
prosthesis 1 to the mitral valve MV through the apical dilated
sheath 341.
[0080] Specifically, the valve delivery device 2 is placed in the
apical dilated sheath 341, and the valve delivery device 2 is
slowly pushed, so that a distal end of an outer sheath 2010 of the
valve delivery device 2 passes through the mitral valve MV, and a
development ring 2011 of the outer sheath 2010 just crosses the
mitral valve MV into the left atrium. Then the apical dilated
sheath 341 is withdrawn back into the left ventricle LV.
[0081] S133, the valve prosthesis 1 is released from the valve
delivery device, so that the valve prosthesis 1 is located at the
mitral valve MV.
[0082] Specifically, when the position of the valve delivery device
2 is confirmed, a handle of the valve delivery device 2 is rotated
to withdraw the outer sheath 2010 proximally, so that a valve skirt
11 of the valve prosthesis 1 is unconstrained on the left atrium LA
while a valve stent body 12 is still within a cavity of the valve
delivery device 2. At this moment, the position of the valve
prosthesis 1 after being released on the left atrium LA is observed
through a DSA image. If it is found that the release position of
the valve prosthesis 1 is inappropriate, the outer sheath 2010 is
moved distally so that the valve prosthesis 1 is withdrawn into the
outer sheath 2010. The above steps are repeated until it is
confirmed that the release position of the valve prosthesis 1 is
correct, and then the valve prosthesis 1 is completely released.
Then the tether 13 at the proximal end of the valve prosthesis 1 is
pulled out of the left ventricle LV by the valve delivery device 2.
The valve delivery device 2 and the apical dilated sheath 341 are
withdrawn from the heart, the tether 13 is then tightened and fixed
to an outer surface of the left ventricle LV, and the apical
pericardium 301 at the apex of the left ventricle LV is finally
tightened to complete the release of the valve prosthesis 1.
[0083] It should be noted that the structure of the valve delivery
device 2 in the disclosure can be found in CN201711479941.8,
CN201711479996.9, and CN201711487976.6, and will not be described
in detail herein.
[0084] The various technical features of the above-described
embodiments may be combined in any combination, and in order to
simplify the description, all possible combinations of the various
technical features in the above-described embodiments are not
described. However, as long as the combinations of these technical
features do not contradict, they should be considered to be the
scope of the description.
[0085] The above-described examples express only a few
implementations of the disclosure, which are described in greater
detail but are not to be construed as limiting the scope of the
disclosure. It will be appreciated by those of ordinary skill in
the art that numerous variations and modifications may be made to
the disclosure without departing from the concept of the
disclosure, which fall within the protection scope of the
disclosure. Therefore, the protection scope of the disclosure
should be determined by the appended claims.
* * * * *